UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063041 |
|---|---|
| Receipt number | R000072110 |
| Scientific Title | Effects of Continuous Test Food Intake on Bowel Movements: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/18 16:44:23 |
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Basic information
Public title
Effects of Continuous Test Food Intake on Bowel Movements: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study
Acronym
Effects of Continuous Test Food Intake on Bowel Movements
Scientific Title
Effects of Continuous Test Food Intake on Bowel Movements: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study
Scientific Title:Acronym
Effects of Continuous Test Food Intake on Bowel Movements
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of six-week continuous intake of the test food on bowel movements, a randomized, double-blind, placebo-controlled, parallel-group trial will be conducted in healthy males and females aged 20 to under 65 years who have a tendency toward constipation and abdominal discomfort.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation statu
Key secondary outcomes
(1) Stool characteristics
(2) Sensation of defecation and abdominal symptoms
(3) Questionnaires on abdominal discomfort and bowel movements
(4) POMS-2 brief version
(5) Body odor
(6) Breath odor
(7) Gut Microbiota in Fecal Samples
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
6-week intake of test food
Interventions/Control_2
6-week intake of placebo food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese males and females aged 20 years or older and under 65 years at the time of informed consent.
2. Individuals with a tendency toward constipation (usual defecation frequency of 3 to 5 times per week).
3. Individuals with abdominal discomfort.
4. Individuals who have received sufficient explanation of the study, have the capacity to provide informed consent, fully understand the study, and are able to provide electronic informed consent.
Key exclusion criteria
1. Regular use of drugs that affect bowel movements (laxatives, antidiarrheals, etc.).
2. Undergoing treatment for hemorrhoids or experiencing severe pain or bleeding during defecation.
3. Chronic diseases currently under treatment.
4. A history of serious cerebrovascular, heart, liver, kidney, blood, or endocrine diseases.
5. A history of serious gastrointestinal diseases, such as intestinal obstruction or malignancy, or gastrointestinal surgery (e.g., gastrectomy, intestinal suturing, or enterectomy), excluding appendectomy.
6. Diagnosed with or treated for axillary osmidrosis or hyperhidrosis.
7. Risk of allergy to test foods.
8. Individuals whose bowel movements are substantially affected by menstruation or poor physical condition.
9. Unable to stop fermented milk or lactic acid bacteria beverages during the trial.
10. Unable to stop foods for specified health uses, functional foods, or health foods during the trial.
11. Current smokers.
12. Habitual drinkers (approx. 60g alcohol per day).
13. Extremely irregular sleep or diet (shift or night workers).
14. Potential major changes in living environment, diet, or exercise during the trial.
15. Women who are breastfeeding, pregnant, potentially pregnant, or planning pregnancy.
16. Current, recent (within 4 weeks of screening), or planned participation in other clinical trials.
17. Judged inappropriate by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
umin_info@macromillcarenet.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Ikeyama |
Organization
Macromill Carenet, Inc.
Division name
Clinical Research Solution Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-7108
Homepage URL
umin_info@macromillcarenet.jp
Sponsor or person
Institute
Macromill Carenet, Inc.
Institute
Department
Personal name
Funding Source
Organization
Nissin York Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072110
